Phase III Cardiac MRI Subgroup Supports Low-Dose Gadoquatrane
Bayer has announced positive Phase III subgroup results for its investigational gadolinium-based contrast agent (GBCA) gadoquatrane in cardiac magnetic resonance imaging (MRI). According to the company, the data further support the safety and efficacy profile of the low-dose contrast agent and form part of ongoing regulatory submissions to health authorities worldwide.
The results are derived from a predefined cardiac MRI subgroup within the pivotal Phase III study QUANTI OBR (Other Body Regions), which is part of Bayer’s broader QUANTI clinical development program. The subgroup analysis was presented at the annual meeting of the Society for Cardiovascular Magnetic Resonance (SCMR) 2026.
Reduced Gadolinium Dose in Cardiac MRI
In the QUANTI program, gadoquatrane was evaluated at a gadolinium dose of 0.04 mmol Gd/kg body weight. This represents a 60% reduction compared with the standard dose of 0.1 mmol Gd/kg body weight used for currently available macrocyclic GBCAs. The cardiac MRI subgroup included adult patients with known or suspected cardiac pathologies undergoing contrast-enhanced MRI.
Images were assessed through a blinded, independent central read using pre-specified qualitative visualization parameters, including contrast enhancement, lesion delineation, and morphology. According to Bayer, gadoquatrane demonstrated similar efficacy and safety compared to established macrocyclic contrast agents, while maintaining diagnostic image quality at the reduced dose.
When compared with non-contrast cardiac MRI scans, gadoquatrane showed clear improvements across visualization parameters. These findings are consistent with results from the overall QUANTI OBR study, in which the investigational agent met all primary and secondary endpoints.
Clinical Relevance for Cardiac Imaging
“Contrast-enhanced cardiac MRI is a noninvasive, radiation-free imaging technique that enables clinicians to make accurate diagnoses and prognoses and to select treatments for patients with a wide range of cardiovascular conditions,” said Prof. Julian Luetkens, Director of the Department for Diagnostic and Interventional Radiology at the University Hospital Bonn. “Patients undergoing contrast-enhanced MRI may benefit from a lower Gd dose, as it reduces their lifetime exposure, especially for those who require multiple scans throughout their lives and populations such as renally impaired and pediatric patients.”
The QUANTI OBR cardiac subgroup comprised 36 evaluable patients. Referral diagnoses included cardiomyopathies, myocarditis, ischemia, and other cardiovascular conditions.
Regulatory Pathway and Development Program
The QUANTI clinical development program includes two large multinational Phase III studies—QUANTI CNS (Central Nervous System) and QUANTI OBR—as well as the QUANTI Pediatric study. In total, 808 patients across 15 countries participated. Across all studies, gadoquatrane met primary and secondary efficacy endpoints while demonstrating a safety profile consistent with other macrocyclic GBCAs, with no new safety signals observed.
Based on these data, Bayer has submitted applications for marketing authorization for gadoquatrane in multiple regions, including Japan, the United States, the European Union, and China.
“As cardiovascular conditions rise, cardiac MRI use has grown substantially in recent years – shifting from a specialized procedure to a cornerstone of patient care and a key tool in precision cardiology, and Bayer remains committed to driving innovation in this field,” said Dr. Konstanze Diefenbach, Head of Radiology R&D at Bayer’s Pharmaceuticals Division. “QUANTI results point to gadoquatrane's promise as a low-dose MRI contrast agent across a wide range of clinical settings, including cardiac imaging. A low-dose approach aligns with guidance from health authorities and scientific bodies to use the minimum dose necessary for clinical decisions. We look forward to working with regulators worldwide to bring gadoquatrane to patients and clinicians as quickly as possible.”
Source: Bayer AG
